1. Purpose

To define preparation for, conduct of and follow-up to sponsor and contract research organisation monitoring visits, including timely resolution of data queries and action items.

2. Scope

Applies to site initiation visits, interim monitoring visits, remote monitoring, close-out visits and all data queries raised through the electronic data capture system.

3. Responsibilities

• Director of Clinical Operations: Ensures visits are resourced and action items are closed on schedule.
• Clinical Research Coordinators: Prepare records, host the monitor, and resolve queries within the required interval.
• Data Management: Tracks open queries, monitors aging, and reports metrics to the study team.
• Principal Investigator: Meets the monitor at each visit as required and signs follow-up letters.

4. Definitions

Source data verification

Comparison of data in the case report form against the original source records.

Query

A question raised on a data point in the electronic data capture system requiring site response or correction.

Follow-up letter

The monitor's written summary of visit findings and action items sent to the site after the visit.

Remote monitoring

Monitoring performed without an on-site visit, using secure access to records or certified copies.

5. Procedure

1. Confirm the visit date, agenda and record request at least ten business days in advance, and reserve a private workspace with no incidental access to non-study protected health information.
2. Complete data entry for all visits occurring more than five business days before the monitoring visit, and resolve outstanding queries where possible.
3. Prepare the regulatory binder, source documents, consent documents, delegation log, training records, investigational product accountability and specimen logs for review.
4. Verify monitor authorisation and confirm the scope of record access permitted by the clinical trial agreement; provide access only to study-related records.
5. Supervise all record review; never leave a monitor unattended with subject records, and log the records provided.
6. Support remote monitoring only through approved secure methods, with certified copies or read-only access under IT & Security control per HIP-002; never send protected health information by unencrypted email.
7. Attend the monitor's summary discussion, record findings, and ensure the Principal Investigator meets the monitor where required by the protocol.
8. Review the follow-up letter within five business days of receipt, assign an owner and target date to each action item, and record them in the site action log.
9. Close routine action items within thirty calendar days and safety or consent-related items within ten business days; escalate anything at risk of slipping to the Director of Clinical Operations.
10. Respond to electronic data capture queries within five business days of issue, correcting the case report form only when supported by source documentation.
11. Where source data is wrong, correct the source record using a single line-through, corrected entry, initials and date, with a brief reason as required by DAT-001.
12. Report any finding that constitutes a protocol deviation under CON-002 or a privacy incident under HIP-003.
13. File the follow-up letter, the site response and evidence of closure in the regulatory binder.

6. References

• ICH E6(R3) Good Clinical Practice, monitoring
• 21 CFR Part 312.56 — Review of ongoing investigations
• DAT-001 Source Documentation & ALCOA+ Principles
• HIP-002 HIPAA Security Rule Safeguards

7. Revision History

• v1.0 · Mar 02, 2021 — Initial issue.
• v2.0 · May 05, 2025 — Added remote monitoring controls and query response timelines.